US Regulators Clear Way for More Monkeypox Vaccine Shipments

People stand in long lines to receive the monkeypox vaccine at San Francisco General Hospital in San Francisco, Tuesday, July 12, 2022. (Jessica Christian/San Francisco Chronicle via AP)

Thousands more doses of monkeypox vaccine are expected to soon begin shipping to the U.S. after federal health officials said they had completed an inspection of the overseas plant where they were manufactured.

The update from the Food and Drug Administration comes amid soaring demand for the two-dose vaccine as thousands of people in New York City, California and other parts of the U.S. await a chance to get the shot.

More than 1.1 million doses of the vaccine purchased by the U.S. government are currently at Bavarian Nordic’s facility in Denmark. The company said earlier this week it needed authorization from an on-site FDA inspection before it could ship them to the U.S.

An FDA spokeswoman said late Wednesday that regulators “expedited and completed an inspection of the company’s plant.”

“We do not expect any delay in vaccine availability due to this process,” she said in an emailed statement.

Bavarian Nordic has already shipped 300,000 vaccine doses that were made at a third-party facility that had previously been authorized by the FDA.

The FDA requires prior inspections of all vaccine plants to assure their safety, sterility and consistency of production. A company spokesman said Bavarian Nordic sped up its plans to undergo the inspection after monkeypox began spreading in Europe in May. Initially the company planned to submit its paperwork to the FDA in August for an inspection later in the fall.

Bavarian Nordic’s two-shot Jynneos is one of two vaccines that can be given in the U.S. to prevent monkeypox. The government has many more doses of an older smallpox vaccine — ACAM2000 — that can also be used, but it is considered to have a greater risk of side effects and is not recommended for people who have HIV. So it’s the Jynneos vaccine that officials have been using as a primary weapon against the outbreak.

Most monkeypox patients experience only fever, body aches, chills and fatigue. People with more serious illness may develop a rash and lesions on the face and hands that can spread to other parts of the body.

Most of the roughly 1,000 cases reported in the U.S. have been among men who have sex with men, but health officials stress that anyone can get the disease. The current number of U.S. cases reported is likely an undercount because testing is still ramping up.

White House officials have promised more supplies, chiefly from the more than 1 million-dose Bavarian Nordic stockpile. The U.S. has ordered another 2.5 million doses for delivery later this year or early next.

Last month, New York-based activists blasted the FDA for not moving more swiftly to inspect the company’s plant and begin shipping the vaccines to the U.S. In a letter to the White House, the HIV non-profit PrEP4All noted that European regulators had signed off on the plant last year.

While the FDA relies on inspections by foreign regulators to review some facilities, the FDA said it conducts its own inspections for vaccines “to ensure consistency in the inspection process.”



  1. The monkeypox virus outbreak is growing in the United States and elsewhere, with the US Centers for Disease Control and Prevention (CDC) now reporting 605 cases in 34 states, the District of Columbia, and Puerto Rico.

    New York has the most cases, with 122, followed by California with 116 and Florida with 64.

    The virus is affecting rural states, too, with Idaho now reporting its first case. The patient is an adult who likely acquired the infection during travel to a country experiencing an outbreak.
    Copied from University of Minnesota’s CIDRAP website:

    According to the latest situation update from the World Health Organization (WHO) published yesterday, global cases of the virus increased 77% in the past week.

    41% of patients HIV-positive
    The WHO update also noted that among monkeypox patients with known HIV status, 41% were HIV-positive. Among cases with reported sexual orientation, 60% (1,214 of 2,025) identified as gay, bisexual, and other men who have sex with men.